Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of primary teeth anesthesia using nasal spray in children

Conditions: Dental Caries

Summary: 68 healthy children from the department of pediatric dentistry at damascus university who require treatment for their primary maxillary second molars will be randomly assigned into one of two groups: experimental or control groups. in the experimental group, a lidocaine hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper second molar before the commencement of treatment. to assess the efficacy of this kind of anesthesia, a specific scale will be used by an external observer after capturing some video files of the performed treatment. to assess the safety of this procedure, vital signs will be recorded before and after treatment. acceptance of the nasal spray will be recorded based on the child's behavior before and after treatment using frankl scale. if anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be used. rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2% with epinephrine hydrochloride (1:100,000). in the control group, an intra-oral lidocaine-epinephrine injection will be applied due to treatment. safety, efficacy and acceptance will be assessed in the same manner to what is performed in the experimental group.

the most common method for anesthetizing maxillary teeth is infiltration injection of an anesthetic agent. this approach carries several disadvantages. first is the child's fear of pain. infection is also a risk for providers, through exposure to blood-borne pathogens via needle stick. fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist. importantly, patients' fear of injections can delay needed dental care. surveys indicate that 30-40 million people in the us avoid going to the dentist because of fear of pain and anesthetic injections. therefore an anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a "shot," would greatly benefit dental patients. further, for procedures involving more than one maxillary tooth on the same side, a trans-nasally applied anesthetic agent that could anesthetize multiple maxillary teeth at once instead of use of repeated infiltration injections would be a major convenience for patients and dentists.

Eligibility criteria:
inclusion criteria: 1. healthy children between 7-10 years. 2. with a need for pulpotomy or a restorative dental procedure requiring local anesthesia for a single vital primary maxillary second molar with no evidence of pulpal necrosis. 3. normal lip, nose, eyelid, and cheek sensation. 4. no history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride. exclusion criteria: 1. frequent bleeding form the nose (≥ 5 per month) 2. inadequately controlled active thyroid disease of any type. 3. having received dental care requiring a local anesthetic within the 24 hours preceding study entry. 4. history of allergy to or intolerance of lidocaine or epinephrine.
survey to assess physicians' knowledge of exjade posology and biological monitoring recommendations as described in the educational materials

Conditions: Chronic Iron Overload

Summary: the objective of this survey is to assess the knowledge of hcps in relation to the recommended posology and biological monitoring for exjade, based on the current locally valid exjade educational materials (including the physician's reference checklist)


Eligibility criteria:
inclusion criteria: physicians will be required to meet all of the following inclusion criteria: * must provide consent for participation * must spend ≥50% of time in direct patient care * have treated patients with transfusional iron overload or non-transfusion-dependent thalassemia with chelation therapy during the last 12 months. * have prescribed exjade and/or generic deferasirox within the last 12 months. exclusion criteria: physicians meeting the following criterion will not be eligible to take the survey: • currently employed by a pharmaceutical company, health care company, market research company, advertising agency, or government agency involved in pharmaceutical research or marketing.

Keywords: physician survey, pas, deferasirox
effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with esophageal gastric varices

Conditions: Esophageal Varices Secondary to Cirrhosis of Liver

Summary: the main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy. about 30% to 70% patients with cirrhosis occur esophageal varices, and the most common complication is ascites. somatostatin is used to treat esophageal for a long time, otherwise it could aslo prevent ascites. in the study, the investigators explore the effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with esophageal gastric varices.

126 patients will be enrolled in the study, 63 subjects will be randomized into the group a and the other will be into the group b. group a: endoscopic therapy and somatostatin treatment. group b: endoscopic therapy.

Eligibility criteria:
inclusion criteria: * cirrhosis with esophageal gastric varices needed endoscopic therapy * age 18-75 years * informed written consent exclusion criteria: * use of vasoactive drugs 24 hours before endoscopic treatment * use of b-blocker within 1 week * previous surgical or endoscopic treatment for esophageal gastric varices * hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy * gastro-renal vein shunt * severe hepatic hydrothorax * hepatocellular carcinoma with portal vein thrombosis * severe coagulation disorders * severe active bacteria infection * severe cardiovascular disease, including a history of acute myocardial infarction,heart block, heart failure * severe renal function insufficiency （calculated creatinine clearance rate (ccr) \<30ml/min） * severe co-morbidity that would affect short-term prognosis * pregnancy or lactation * allergy to any ingredient of trial medication * medical or psychological condition that would not permit the patient to complete the study or sign the informed consent
efficacy and safety of combination of rosuvastatin and ezetimibe in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: the purpose of this study is to evaluate efficacy and safety of hl140 in patients with primary hypercholesterolemia.

the purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe

Eligibility criteria:
inclusion criteria: * aged over 19 years * signed informed consent form * at visit 1 and visit 2, ldl-cholesterol ≤ 250mg/dl and triglyceride ≤ 400mg/dl exclusion criteria: * at visit 1, bmi ≥ 30kg/㎡ * has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(hmg-coa reductase inhibitor) and component of ezetimibe * has a severe renal disorder(ccr \<30ml/min) or nephrotic syndrome * creatine kinase \> 5 x upper limit of normal * alt or ast \> 3 x upper limit of normal * has a activity/chronic hepatic disease or hiv-positive * has a endocrine or metabolic diseases known to affect the serum phospholipid or protein * uncontrolled diabetes mellitus(hba1c ≥9%) * hypothyroidism (tsh \> 1.5 x upper limit of normal rate at the screening ) * uncontrolled hypertension (sbp ≥180mmhg or dbp ≥110mmhg) * has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening) * severe heart failure (nyha class iii or iv) * has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder * history of malignant tumor including myelogenous and lymphoma within 5 years (participation is possible, if the tumor has not recurred for more than 5 years) * subject with genetic deficiency such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption * female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms) * pregnant or breast-feeding * patients who have a drug or alcohol abuse or are being treated for psychological disorder * patients who were treated with other investigational drug within 12 weeks prior to screening * other patients who are inappropriate to participate in the study considered by the investigator or other study staffs
the frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Summary: this mixed cohort study will test the frequency of pcos among young females presenting with one of the clinical hyperandrogenism criteria: acne, hirsutism and/or hair loss. diagnosis will be based on the recent pcos clinical, biochemical and biophysical criteria recently published " international evidence-based guideline for the assessment and management of polycystic ovary syndrome (pcos) 2018".

irregular menstrual cycles are defined as: * normal in the first year post menarche as part of the pubertal transition * \> 1 to \ 45 days * \> 3 years post menarche to perimenopause: \ 35 days or \< 8 cycles per year * \> 1 year post menarche \> 90 days for any one cycle * primary amenorrhea by age 15 or \> 3 years post thelarche (breast development) when irregular menstrual cycles are present a diagnosis of pcos should be considered. biochemical hyperandrogenism: calculated free testosterone, free androgen index or calculated bioavailable testosterone. androstenedione and dehydroepiandrosterone sulfate (dheas) could be considered if total or free testosterone are not elevated. (eliza or radioimmunoassay). a comprehensive history and physical examination should be completed for symptoms and signs of clinical hyperandrogenism, including acne, alopecia and hirsutism and, in adolescents, severe acne and hirsutism using the modified ferriman gallwey score (mfg). transvaginal (transabdominal if virgins) ultrasound and polycystic ovarian morphology: ultrasound should not be used for the diagnosis of pcos in those with a gynaecological age of \< 8 years (\< 8 years after menarche), due to the high incidence of multi-follicular ovaries in this life stage. transabdominal ultrasound reporting is best focused on ovarian volume with a threshold of ≥ 10ml. endovaginal u/s should show a follicle number per ovary of ≥ 20 and/or an ovarian volume ≥ 10ml, ensuring no corpora lutea, cysts or dominant follicles are present.

Eligibility criteria:
inclusion criteria: * clinical hyperandrogenism exclusion criteria: * age less than 15 or more than 35 years.
discharge medication use post-operatively in gu cancer patients

Conditions: Genitourinary Cancer

Summary: the main purpose of this research study is to determine the amount of opioids that are taken after discharge following a cystectomy, nephrectomy (partial or total), or prostatectomy surgeries via a 30-day post- discharge opioid use and disposal survey. we will also evaluate the impact of an opioid disposal education pamphlet on proper disposal of unused opioids.

this prospective, non-therapeutic trial aims to evaluate the amount of prescribed opioid medications gu cancer patients are consuming post-discharge following surgical procedure of cystectomies, nephrectomies, and prostatectomies. enrolled participants will complete a 30-day post-discharge survey evaluating the usage of prescribed opioids and opioid disposal habits, as well as a patient satisfaction survey. furthermore, participants will be offered to complete an optional cahps® surgical care survey to assess patients' experiences with surgical care during in hospital stay and outpatient office visits. education on opioid medication disposal will be provided in the form of a pamphlet to participants that are enrolled beginning in year 2 (approximately month 13) from when the first participant is enrolled or after a minimum of 100 evaluable participants are enrolled in the pre-education cohort.

Eligibility criteria:
inclusion criteria: 1. written informed consent and hipaa authorization for release of personal health information. 2. age ≥ 18 years at the time of enrollment 3. scheduled to undergo surgical cystectomy, partial or total nephrectomy or prostatectomy for a cancer diagnosis. 4. ability to read and understand the english and/or spanish language. 5. enrolling investigator plans to prescribe opioids at the time of discharge for post-operative pain. 6. as determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study. exclusion criteria: * none

Keywords: genitourinary cancer cystectomies nephrectomies prostatectomies
a pilot study of exercise in patients with docetaxel-based chemotherapy for hormone refractory prostate cancer

Conditions: Prostatic Neoplasms; Neoplasm Metastasis; Palliative Care

Summary: this study aims to provide preliminary data on the feasibility and outcomes of a 12 week exercise program on the quality of life of men with hormone refractory prostate cancer receiving docetaxel-based chemotherapy.


Eligibility criteria:
inclusion criteria: * diagnosis of prostate cancer * receiving docetaxel-based chemotherapy at the cci * age 18 years or over * approval of oncologist * informed written consent exclusion criteria: * life expectancy less than 6 months * karnofsky performance score less than 70 * contraindications for exercise (e.g. uncontrolled cardiac, respiratory, hypertensive or psychiatric disorder) * unable to understand, read, write and speak english * unable or unwilling to attend supervised exercise sessions 3 times weekly * unable or unwilling to complete outcome assessments

Keywords: exercise exercise therapy activities of daily living quality of life
use of electropalatography to improve speech sound production

Conditions: Hearing Impairment

Summary: the purpose of this proposed study is to examine the benefits of using electropalatography (epg) during speech therapy with adult individuals who are either congenitally deaf or adventitiously deaf and use a cochlear implant.

it has been established in numerous research studies that there is a definitive link between speech perception and speech production, in that what one can perceive, one can produce. hearing loss disrupts this link and while cochlear implants make a significant difference in perception of sound, adults who are deaf and receive a cochlear implant (ci) do not gain the same perceptual benefits as children who are deaf and are implanted at a young age. thus, the speech production of the adult ci user is reported to be less intelligible. the purpose of this proposed study is to examine the benefits of using electropalatography (epg) during speech therapy with adult individuals who are either congenitally deaf or adventitiously deaf and use a cochlear implant. the investigators have proposed to study 10 ci users (5 in each etiological group) who will undergo speech intelligibility testing, and receive speech therapy (1x/week for 10 weeks) using epg that provides both visual (biofeedback) and auditory feedback. it is hypothesized that the biofeedback in addition to the auditory feedback from the ci will result in an increase in articulation skills and thus the speech intelligibility in these individuals will improve significantly.

Eligibility criteria:
inclusion criteria: * all participants in this study will be at least 3 years post-implant and they must use the implants consistently. * participants who have adventitious/acquired hearing loss must have had normal hearing through their 18th year. * participants with congenital hearing loss will have received oral or total communication education, worn hearing aids and consider themselves to be "oral deaf" adults. exclusion criteria: * individuals who do not meet this criteria will be excluded from the protocol.
safety, tolerability and pharmacokinetics of qak423a in healthy volunteers and chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: there are three elements to this study: * part a: single dose escalation in healthy subjects. 6 dose levels of qak423 are planned in healthy volunteers. * part b: single dose escalation in patients with mild/moderate copd. 3 dose levels of qak423 are planned in copd patients. * part c: titrated repeat dosing for a maximum of 14 days in mild/moderate copd patients. repeat dosing is planned in copd patients.


Eligibility criteria:
inclusion criteria: part a: * healthy, male subjects aged 18-55 years of age able to provide written informed consent prior to study participation and determined as in good health by past medical history, physical examination, ecg, laboratory tests and urinalysis. parts b and c: * male or female (post menopausal or surgically sterilized) patients with copd, aged 40-75 years, with a smoking history of at least 10 pack years (i.e. smokers or ex-smokers). * diagnosis of mild or moderate copd, according to the gold guidelines. * post-bronchodilator fev1 at screening 50-80% of predicted. * no copd exacerbations within the 3 months prior to dosing, no concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery. * no medical conditions that may jeopardize the subjects participation in the study * weigh less than 100 kg exclusion criteria: * use of any prescription drug or over-the-counter (otc) medication within 2 weeks prior to dosing. * history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. * history of clinically significant drug allergy. a known hypersensitivity to the study drug or drugs similar to the study drug. other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic obstructive pulmonary disease
postoperative follow up after head and face reconstructive surgeries

Conditions: Deformity of Face

Summary: in this observational follow-up study, patients with type iii-iv head and face soft tissue deformities/defects following reconstructive surgeries will be asked to fill out 3 questionnaires, either through phone calls or video calls, in order to evaluate the post-operative outcomes such as morphological and functional recovery, quality of life and patients' return to the community.

the objective of this follow up study is to evaluate the effectiveness and to analyze the limitations of the existing management and treatment of severe burn injuries. investigation of the factors affecting the recovery and patients' return to the community in patients with severe burn injury may lead to effective amendments of the existing management, and thus aiding in the development of an integrated diagnosis and treatment guidelines.

Eligibility criteria:
inclusion criteria: 1. preoperative facial soft tissue deformities/defects of type iii and iv 2. major reconstructive surgery of the head and neck (flap transfer with revision at least once) performed before january 1, 2019. 3. agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent. exclusion criteria: 1. patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate. 2. minor patients without legal guardian. 3. not willing to participate; informed consent form not signed.
pediatric teduglutide registry

Conditions: Short Bowel Syndrome

Summary: pediatric specific post-marketing registry to evaluate the long-term safety and efficacy of teduglutide.

this will be a multi-center post-marketing pediatric registry study evaluating the efficacy and safety of teduglutide. this is an observational longitudinal registry of pediatric sbs patients who are using fda approved teduglutide as per standard of care.

Eligibility criteria:
cohort a: inclusion criteria: 1. diagnosis of sbs defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on ps for 90 days 2. received teduglutide after fda approval 3. age ≥ 1 years and ≤ 18 years at start of teduglutide initiation 4. weight ≥ 10 kg at start of teduglutide initiation 5. dependent on ps at the time of teduglutide initiation 6. subject data for primary outcome (ps energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit. 7. the subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. exclusion criteria: 1. participation in the pediatric clinical trial studies of teduglutide (ted-c13-003, ted-c14-006 or shp633-303, shp633-304). 2. in the opinion of the investigator, the subject or guardian is at high risk for non-compliance. cohort b: inclusion criteria: 1. diagnosis of sbs defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on ps for 90 days 2. participated in clinical trial study (ted-c13-003, ted-c14-006) and/or extension study (shp633-303, shp633-304) 3. currently receiving teduglutide 4. the subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. exclusion criteria: 1. in the opinion of the investigator, the subject or guardian is at high risk for non-compliance.
effectiveness of magnesium in addition to prochlorperazine for the treatment of migraines

Conditions: Migraine

Summary: the purpose of this research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.

the purpose of this prospective, randomized, double-blinded study is to compare the relative efficacy and safety of intravenous magnesium in conjunction with intravenous prochlorperazine in the treatment of migraines. participants will be patients presenting to the emergency department with primary diagnosis of migraine.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years or older * able to provide informed consent * english speaking * primary diagnosis of migraine. patient with a previous diagnosis of migraine, who experience headaches with typical migraine features (e.g at least 2-3 of the following: recurrent, unilateral, pounding or throbbing in nature, associated with nausea), and with a clinical exclusion of migraine mimics exclusion criteria: * pregnancy defined as a positive urine hcg * allergy or sensitivity to study drug * stated history of renal insufficiency * documented history of myasthenia gravis * consumption of study drug within 48 hours prior to enrollment * previously enrolled in this trial during a different patient encounter

Keywords: migraine magnesium